Table 11:

Results of Economic Literature Review—Summary

Author, Year Country of Publication	Study Design, Analytic Technique, Perspective, Discounting, Time Horizon	Population	Intervention and Comparator	Results
				Health Outcomes	Costsa	Cost-Effectiveness
Tanner et al, 202078 Canada	Study design: Model-based CEA Analytic technique: Markov cohort model Perspective: Canadian public health care system (i.e., public payer including both direct and indirect costs) Discounting: 3% Time horizon: 5 y	Adults with moderate to severe major depression Mean age, y: 32 Female, %: NR	Intervention: PGx-guided treatment Comparator: TAU (no PGx)	Mean QALYs, intervention, and TAU: NR Mean difference, intervention vs. TAU: 0.168	Currency, y: 2018 CAD Total (direct, indirect, and testing) costs (mean), intervention, and TAU: NR Total costs, mean difference: –$2,431 PGx test cost (GeneSight): $2,500	Reference case: Compared with TAU, PGx-guided treatment is dominant (more effective and cost saving) Sensitivity analyses: Three more analyses address differences in effectiveness of intervention. In all analyses, intervention was dominant PSA: 94.5% to 96.7% chance of PGx-guided treatment being cost-effective over TAU at WTP of $50,000/QALY in the analyses One-way deterministic analyses of key drivers: rate of remission (assuming a 25% lower rate of remission led to incremental costs of the intervention, but ICER remained < $50,000/QALY)
Groessl et al, 201879 United States	Study design: model-based CEA Analytic technique: Markov cohort model Perspective: societal Discounting: 3% Time horizon: 3 y	Adults with moderate to severe major depression, treatment naive or with inadequately controlled disease Mean age, y: 48 Female, %: NR	Intervention: PGx-guided treatment Comparator: TAU (no PGx)	Mean QALYs for intervention and TAU: 2.07 and 1.97 Mean difference for intervention vs. TAU: 0.10	Currency, y: USD, 2016 Total (direct, indirect, and testing) costs (mean) for intervention and TAU: $44,697 and $47,295 Direct medical costsb (mean) for intervention and TAU: $29,990 and $32,908 Total costs, mean difference: –$2,598 Direct medical costs,b mean difference: –$2,918 PGx test cost (IDgenetix): $2,000	Reference case: compared with TAU, PGx-guided treatment is dominant (more effective and cost saving) Sensitivity analyses: PSA was not done One-way deterministic analyses: results were robust despite changes to response rate, costs, utilities
Najafzadeh et al, 201781 United States	Study design: model-based CEA Analytic technique: discrete event simulation model Perspective: societal Discounting: 3% Time horizon: 3 y	Adults with moderate or severe major depression or anxiety, receiving treatment level 1 as per the STAR∗D study (citalopram or equivalent therapy)8,88 Mean age, y: 48 (SD 14.5) Female, %: 73	Intervention: PGx-guided treatment Comparator: TAU (no PGx)	Mean QALYs for intervention and TAU: 2.09 (95% CrI: 1.88 to 2.28) and 1.94 (95% CrI: 1.66 to 2.21) Mean difference for intervention vs. TAU: 0.15 (95% CrI: 0.04 to 0.28)	Currency, y: USD, 2017 Total (direct, indirect, and testing) costs (mean) for intervention and TAU: $14,124 (95% CrI: $10,703 to $17,630) and $14,659 (95% CrI: $10,384 to $19,275) Direct medical costsb (mean) for intervention and TAU: $10,530 (95% CrI: $7,487 to $13,600) and $10,323 (95% CrI: $6,568 to $14,433) Total costs, mean difference: –$535 (95% CrI: –$2,902 to $1,692) Direct medical costs,b mean difference: $207 (95% CrI: considered?–$1,671 to $2,022) PGx test cost (IDgenetix): $2,000	Reference case: compared with TAU, PGx-guided treatment is dominant (more effective and cost saving) Sensitivity analyses: PSA: 98% chance of PGx-guided treatment being cost-effective over TAU at WTP of $50,000/QALY One-way deterministic analyses of key drivers time horizon (< 1 y: ICER > $50,000/QALY) and study perspective (if direct medical costs including testing were considered: ICER $1,394/QALY)
Hornberger et al, 201580 United States	Study design: model-based CEA Analytic technique: Markov cohort model Perspective: societal Discounting: 3% Time horizon: lifetime	Adults with major depression nonresponsive (did not benefit from) ≥ 1 course of antidepressant therapy Mean age, y: 44 Female, %: NR	Intervention: PGx-guided treatment Comparator: TAU (no PGx)	Mean QALYs for intervention and TAU: 13.624 and 13.308 Mean difference, intervention vs. TAU: 0.316	Currency, y: USD, 2013 Total (direct, indirect, and testing) costs (mean) for intervention and TAU: $272,751 and $276,515 Direct medical costsb (mean for intervention and TAU: $208,260 and $211,971 Total costs, mean difference: –$3,764 Direct medical costs,b mean difference: –$3,711 PGx test cost (GeneSight): $2,500	Reference case: compared with TAU, PGx-guided treatment is dominant (more effective and cost saving) Sensitivity analyses: PSA: 94.5% chance of PGx-guided treatment being cost-effective over TAU at WTP of $50,000/QALY in the analyses One-way deterministic analyses of key drivers: cost of PGx ($3,125 vs. $2,500) or duration of catch-up period (1 y vs. 3 y) led to incremental costs of the intervention, but the ICER remained < $50,000/QALY

Abbreviations: CEA, cost-effectiveness analysis; ICER, incremental cost-effectiveness ratio; NA, not applicable; NR, not reported; PGx, multi-gene pharmacogenomic test; STAR∗D study, Sequenced Treatment Alternatives to Relieve Depression; PSA, probabilistic sensitivity analysis; QALY, quality-adjusted life-year; SD, standard deviation; TAU, treatment as usual; USD, United States dollars; WTP, willingness to pay.

^aNegative costs indicate savings.

^bCost estimate did not include cost of testing.